K243053
- 510(k) number
- K243053
- Device name
- Navient Image Guided Navigation System (ENT) (955-NC-NC)
- Applicant
- Claronav CA
- Product code
- PGW — Ear, Nose, And Throat Stereotaxic Instrument
- Decision date
- 2025-06-20
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243053.pdf
Official FDA record: K243053
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.